Last Update: Jul 29, 2026 Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers ClinicalTrials.gov Identifier: [NCT06562192](https://clinicaltrials.gov/ct2/show/NCT06562192) Novartis Reference Number:CFXX489A12101 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \\\[177Lu\\\]Lu-NNS309 and the safety, dosimetry and imaging properties of \\\[68Ga\\\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC). The study will be done in two parts. The first part is called "escalation" and the second part is called "expansion". In both parts of the study, patients will initially be imaged with a \\\[68Ga\\\]Ga-NNS309 positron emission tomography (PET)/ computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan and will be evaluated for eligibility for \\\[177Lu\\\]Lu-NNS309 treatment. In the escalation part, different doses of \\\[177Lu\\\]Lu-NNS309 will then be tested to identify recommended dose(s) (RD(s)) for further evaluation. The expansion part of the study will examine the safety and preliminary efficacy of \\\[177Lu\\\]Lu-NNS309 at the RD(s) determined during the escalation part. The end of study will occur when all patients per disease group in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason, and all patients have completed treatment and the 36-month long-term follow-up period. Condition Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer, Colorectal Cancer Phase Phase1 Overall Status Recruiting Number of Participants162 Start Date Oct 15, 2024 Completion Date Jan 16, 2031 Gender All Age(s) 18 Years - 100 Years (Adult, Older Adult) ## Interventions Drug ### \[177Lu\]Lu-NNS309 Radioligand therapy Drug ### \[68Ga\]Ga-NNS309 Radioligand imaging agent ## Eligibility Criteria Inclusion Criteria: \* Age ≥ 18 years old \* Patients with one of the following indications: \* Locally advanced unresectable or metastatic PDAC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy \* Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to targeted therapy, unless patient was ineligible to receive such therapy \* Locally advanced unresectable or metastatic HR+/HER2- ductal or lobular BC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy \* Locally advanced unresectable or metastatic TNBC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy \* Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy \* Patients must have lesions showing 68Ga-NNS309 uptake Exclusion Criteria: \* Absolute neutrophil count (ANC) \\< 1.5 x 10\\^9/L, hemoglobin \\< 9 g/dL, or platelet count \\< 100 x 10\\^9/L \* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec \* Calculated estimated glomerular filtration rate \\< 60 mL/min/1.73m2 \* Unmanageable urinary tract obstruction or urinary incontinence \* Radiation therapy within 4 weeks prior to the first dose of \\\[177Lu\\\]Lu-NNS309 Other protocol-defined inclusion/exclusion criteria may apply. Belgium #### Novartis Investigative Site Recruiting Brussels,1000,Belgium Canada #### Novartis Investigative Site Recruiting Montreal,Quebec,H2x 1r9,Canada #### Novartis Investigative Site Recruiting Toronto,Ontario,M5g 2m9,Canada #### Novartis Investigative Site Recruiting Montreal,Quebec,H3t 1e2,Canada France #### Novartis Investigative Site Recruiting Villejuif,94800,France #### Novartis Investigative Site Recruiting Bron,69677,France Germany #### Novartis Investigative Site Recruiting Cologne,North Rhine-Westphalia,50937,Germany #### Novartis Investigative Site Recruiting Essen,45147,Germany #### Novartis Investigative Site Recruiting München,80377,Germany #### Novartis Investigative Site Recruiting Rostock,18057,Germany Israel #### Novartis Investigative Site Recruiting Tel Aviv,6423906,Israel Italy #### Novartis Investigative Site Recruiting Milan,MI,20133,Italy #### Novartis Investigative Site Recruiting Reggio Emilia,RE,42123,Italy Netherlands #### Novartis Investigative Site Recruiting Nijmegen,Gelderland,6500hb,Netherlands #### Novartis Investigative Site Recruiting Utrecht,3584 cx,Netherlands Spain #### Novartis Investigative Site Recruiting Barcelona,08036,Spain #### Novartis Investigative Site Recruiting Madrid,28009,Spain #### Novartis Investigative Site Recruiting Madrid,28040,Spain Switzerland #### Novartis Investigative Site Recruiting Lausanne,1011,Switzerland #### Novartis Investigative Site Recruiting Geneva,1211,Switzerland United States #### Uni of Alabama at Birmingham Recruiting Birmingham,Alabama,35249,United States ###### Quenteeria Mooney Email: ###### Jonathan McConathy #### Mayo Clinic Jacksonville Recruiting Jacksonville,Florida,32224,United States ###### Ephraim Parent ###### Alberta Lalljie Phone: [+1 904 953 7648]() Email: #### University of California LA Recruiting Los Angeles,California,90095,United States ###### Jonathan W Goldman ###### Angela Lool Email: #### Mayo Clinic Rochester Recruiting Rochester,Minnesota,55905,United States ###### Lucas Hamann Phone: [+1 507 538 2155]() Email: ###### Andrea Wahner Hendrickson #### Stanford University Medical Center Recruiting Palo Alto,California,94304,United States ###### Maria Isabel Leonio Email: ###### Farshad Moradi #### University Of Washington Recruiting Seattle,Washington,98109,United States ###### Heather White Email: ###### Delphine Chen #### Uni Of TX MD Anderson Cancer Cntr Recruiting Houston,Texas,77030,United States ###### Jordi Rodon ###### Denisse Harkins Phone: [+1 713 792 2921]() Email: #### Massachusetts General Hospital Recruiting Boston,Massachusetts,02114,United States ###### Shadi Abdar Esfahani ###### Jonathan Robert Kim Email: #### BAMF Health Recruiting Grand Rapids,Michigan,49503,United States ###### Lisa Orange Email: ###### Brandon Mancini ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: